Dose-ranging Study of SPL7013 Gel for the Prevention of Bacterial Vaginosis (BV)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Starpharma Pty Ltd
ClinicalTrials.gov Identifier:
NCT01437722
First received: September 20, 2011
Last updated: October 27, 2013
Last verified: October 2013
  Purpose

The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.


Condition Intervention Phase
Recurrent Bacterial Vaginosis (BV)
Drug: 1% SPL7013 Gel
Drug: 3% SPL7013 Gel
Drug: placebo gel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis

Further study details as provided by Starpharma Pty Ltd:

Primary Outcome Measures:
  • Number of women who have experienced a recurrent episode of BV as a measure of efficacy [ Time Frame: Day 112 +/- 5 ] [ Designated as safety issue: No ]
    Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria


Enrollment: 205
Study Start Date: August 2011
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1% SPL7013 Gel Drug: 1% SPL7013 Gel
vaginal gel
Experimental: 3% SPL7013 Gel Drug: 3% SPL7013 Gel
vaginal gel
Placebo Comparator: placebo gel Drug: placebo gel
vaginal gel

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
  • Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
  • Otherwise healthy

Exclusion Criteria:

  • No active STIs and/or current UTI
  • Previous exposure to SPL7013 Gel
  • A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437722

Sponsors and Collaborators
Starpharma Pty Ltd
Investigators
Study Director: Jeremy Paull, PhD Starpharma Pty Ltd
  More Information

No publications provided

Responsible Party: Starpharma Pty Ltd
ClinicalTrials.gov Identifier: NCT01437722     History of Changes
Other Study ID Numbers: SPL7013-014
Study First Received: September 20, 2011
Last Updated: October 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Starpharma Pty Ltd:
BV
Bacterial vaginosis
recurrent
SPL7013 Gel
VivaGel

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 22, 2014